Blue Light Cystoscopy for Bladder Cancer

(BLCCR Trial)

Recruiting at 22 trial locations

Overseen By Chad McKee, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Photocure

Disqualifiers: Porphyria, Gross hematuria, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-3 hours per procedure

4400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about how doctors use Blue Light Cystoscopy with Cysview for bladder cancer. The procedure involves a special liquid, hexaminolevulinate hydrochloride (a diagnostic agent), to help doctors better see and treat bladder cancer during an examination. The study seeks individuals suspected or diagnosed with non-muscle invasive bladder cancer based on a previous exam. Participants should not have conditions like porphyria (a rare blood disorder) or a known allergy to the treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Blue Light Cystoscopy with Cysview is safe for bladder cancer patients?

Research has shown that Blue Light Cystoscopy with Cysview, a special imaging dye, is generally safe for patients. Studies have identified common side effects such as bladder spasms, painful urination, blood in the urine, and bladder pain. These side effects are typical for bladder procedures and are usually manageable.

The FDA has already approved Cysview to help detect bladder cancer, indicating it has passed safety checks for that purpose. The procedure uses a light and dye to provide a clearer view inside the bladder during an exam.

For those considering joining a registry study, this treatment has been used before, and the side effects are known. However, discussing any concerns or questions with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blue Light Cystoscopy with Cysview® because it offers a new way to detect bladder cancer more accurately. Unlike traditional white light cystoscopy, this approach uses the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system, which, when combined with the special agent hexaminolevulinate hydrochloride (HCL), highlights cancerous cells in the bladder with a blue glow. This method can improve the detection of cancerous lesions that might be missed with standard techniques, potentially leading to earlier and more effective treatment. The unique blue light technology and the use of the Cysview® agent are what set this approach apart from existing standard-of-care options.

What evidence suggests that Blue Light Cystoscopy with Cysview is effective for bladder cancer?

Research has shown that Blue Light Cystoscopy with Cysview, which participants in this trial will undergo, detects non-muscle invasive bladder cancer more effectively than traditional methods. This technique reduces the likelihood of cancer recurrence. It makes cancer cells glow under blue light, aiding doctors in their removal. This method can identify tumors that regular white light might miss. Overall, it provides a better approach to managing bladder cancer by enhancing detection and reducing recurrence. ^{2 3 5 6 7}

Who Is on the Research Team?

Siamak Daneshmand, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

Inclusion Criteria

Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo Blue Light Cystoscopy with Cysview for bladder cancer detection

1-3 hours per procedure

1 visit (in-person) per procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Data Collection

Data is captured longitudinally over five years on patients from each enrolled site

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hexaminolevulinate hydrochloride (HCL)
• Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

How Is the Trial Designed?

Group I: Blue Light Cystoscopy with Cysview® Experimental Treatment 2 Interventions

Bladder cancer patients who have undergone Blue light cystoscopy with Hexaminolevulinate hydrochloride (Cysview®) 100mg in 50 milliliters (mL) reconstituted solution instilled intravesically into bladder prior to cystoscopy in operating room (OR). Retention time: 1-3 hours. The Karl Storz D-Light C Photodynamic Diagnostic (PDD) system is used for the cystoscopy procedure at the OR examination.

Who Is Running the Clinical Trial?

Photocure

Lead Sponsor

Trials

25

Recruited

27,300+

Catalyst Pharmaceutical Research

Industry Sponsor

Trials

2

Recruited

4,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11181828/

Economic Outcomes of Hexaminolevulinate Blue-Light ... This study seeks to investigate the 5-year cost comparison of BLC and WLC from the Medicare payer perspective.

2. cysviewhcp.com cysviewhcp.com/evidence-and-patient-cases/

Clinical evidence supporting use of Blue Light Cystoscopy ... Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients with Nonmuscle Invasive Bladder Cancer. J Urol. 2010;184(5):1907–1914. 3.

3. cysview.com cysview.com/

Official site for Cysview information Important Risk & Safety Information for Cysview® (hexaminolevulinate HCl). Cysview is an optical imaging agent used to detect non-muscle invasive bladder cancer ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02560584

A Study of Blue Light Flexible Cystoscopy With Cysview in ... The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during ...

5. urotoday.com urotoday.com/conference-highlights/ibcn-2022/139784-ibcn-2022-20-title-the-impact-of-blue-light-cystoscopy-use-among-non-muscle-invasive-bladder-cancer-patients-in-an-equal-access-setting-implications-on-recurrence-and-time-to-recurrence-by-race.html

IBCN 2022: The Impact of Blue Light Cystoscopy Use ... Some evidence suggests that WLC can fail to detect cases of non-muscle invasive bladder cancer (NMIBC) as compared to BLC, with those tumors ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3531633/

Efficacy and Safety of Hexaminolevulinate Fluorescence ... A total of 86 specimens showed positive results with WLC. Among these cases, 62 cases were confirmed bladder cancer, whereas 24 specimens showed negative ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf

Cysview - accessdata.fda.gov No studies in animals have been conducted to evaluate the carcinogenic potential of hexaminolevulinate hydrochloride. Hexaminolevulinate hydrochloride was ...